The Muscle Relaxation-study

NCT01523886 | Completed Phase 4 Results DMC

• 1 other identifier: 2011-441
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation. The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.

Conditions

Cholecystectomy, Laparoscopic

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less

  The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.

  From surgical incision to last suture has been placed, an expected average of 30 minutes

Secondary Outcomes (12)

• Surgical Space Conditions

  From surgical incision to last suture has been placed, an expected average of 30 minutes.

• Surgical Space Conditions

  From surgical incision to last suture has been placed, an expected average of 30 minutes.

• Surgical Space Conditions

  During dissection of the gallbladder

• Pain

  Preoperatively to 7 days after surgery

• Pain

  At arrival to the postanesthesia care department, 2 hours and 1 day after surgery

Study Arms (2)

Deep neuromuscular blockade

ACTIVE COMPARATOR

Drug: Rocuronium

Moderate neuromuscular blockade

PLACEBO COMPARATOR

Drug: Rocuronium

Interventions

Rocuronium DRUG

Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h

Also known as: Esmeron

Deep neuromuscular blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Scheduled for elective laparoscopic cholecystectomy
• Can read and understand danish
• Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

You may not qualify if:

• Known allergy to medications that are included in the project
• Presence of severe renal disease, neuromuscular disease, reduced liver function
• Nursing or pregnant
• Indication for crash induction
• For fertile women: Missing negative pregnancy-test

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet

Soeborg, 2860, Denmark

Location

Related Publications (1)

• Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.

  PMID: 23461992 DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Mona R Gätke, MD, PH.D.
• Organization: Herlev Hospital

mona.gatke@regionh.dk

004538662420

Study Officials

• Anne K Staehr, MD

  Department of anesthesia, Herlev Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Mona R Gätke, MD, Ph.D

  Department of anesthesia, Herlev Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research assistent

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 1, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

DK (1)